XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Drug Discovery World

SEPTEMBER 4, 2023

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

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pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. The post IQVIA’s report card for clinical trial diversity: must do better appeared first on.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies.

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Drug Discovery World

AUGUST 24, 2023

The Phase I clinical trial of VENT-02, an oral, brain-penetrant NLRP3 inhibitor from Ventus Therapeutics, has launched with the dosing of the first patient. NLRP3 is the best understood member of a family of proteins known as inflammasome receptors.

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VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

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Drug Discovery World

JANUARY 30, 2023

Dominic Elliston , Managing Director of Evoke Galliard and Evoke Incisive Health, shares his take on how effective clinical trial communications is the key to expediting the delivery of new and extraordinary treatments. What’s that got to do with clinical trials? Tell us about yourself, Dominic.

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XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center.

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pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. Personal approach. About the author.

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Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”

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XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

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XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.

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Pharmaceutical Technology

NOVEMBER 28, 2022

According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. . on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

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Drug Discovery World

SEPTEMBER 12, 2022

We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. appeared first on Drug Discovery World (DDW).

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.

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Outsourcing Pharma

MAY 4, 2023

Sam Whittaker is founder, and CEO of multiple clinical trial technology companies, including Greenphire and Mural Health.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

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BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

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Pharma Marketing Network

APRIL 30, 2021

Clinical trials may be one of the very last bastions of a non-customer-focused approach within the pharmaceutical industry. Across the board, from rheumatology to neurology, outcomes that matter most to patients, have traditionally not been captured in clinical trials. How do we increase the diversity of clinical trials?

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Worldwide Clinical Trials

FEBRUARY 22, 2023

Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. Rob: When I was diagnosed, my mother was adamantly against a clinical trial.

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XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. The Xtalks White Paper, The Intersection of Rare Disease and Advanced Therapies: What it Means for Clinical Development , is available for free download. Partnering with regulators early.

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The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

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Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases.

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